Tranexamic acid to reduce bleeding after dental extraction in patients treated with non-vitamin K oral anticoagulants: design and rationale of the EXTRACT-NOAC trial.

A Ockerman, M Vanhaverbeke, I Miclotte, A Belmans, T Vanassche, C Politis, R Jacobs, P Verhamme

Journal: The British journal of oral & maxillofacial surgery 2020;57(10):1107-1112

PMID: 31669068

Full Text on Elsevier Science View on PubMed

Abstract

Bleeding after dental extraction in patients treated with non-vitamin K oral anticoagulants (NOAC) may lead to unplanned reinterventions and interruption of anticoagulation, thereby exposing patients to a risk of thromboembolism. We have designed a study (EXTRACT-NOAC) to investigate whether tranexamic acid (TXA) mouthwash decreases bleeding after extraction in such patients. The study is a randomised, double-blind, placebo-controlled trial. We plan to randomise 236 patients listed for dental extraction and treated with NOAC to 10% TXA mouthwash or placebo. Patients are instructed to use the mouthwash before the dental extraction, and three times a day for three days thereafter. The primary outcome is oral bleeding. Secondary outcomes include type of bleeding, procedural bleeding score, number of reinterventions after oral bleeding, and number of interruptions in NOAC treatment. Any bleeding from sources other than the mouth, and thrombotic events, are recorded as safety outcomes. Patients are followed-up for seven days. This study will provide evidence to guide the management of patients taking NOAC who need teeth extracted.

Address: Oral and Maxillofacial Surgery - Imaging and Pathology research group, Department of Imaging and Pathology, Faculty of Medicine, University of Leuven and Department of Oral & Maxillofacial Surgery, University of Leuven, Leuven, Belgium. Electronic address: [email protected].; Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.; Department of Oral & Maxillofacial Surgery, University of Leuven, Leuven, Belgium.; Leuven Biostatistics and Statistical Bioinformatics Centre, Department of Public Health and Primary Care, University of Leuven, Leuven, Belgium.; Oral and Maxillofacial Surgery - Imaging and Pathology research group, Department of Imaging and Pathology, Faculty of Medicine, University of Leuven and Department of Oral & Maxillofacial Surgery, University of Leuven, Leuven, Belgium; Department of Dental Medicine, Karolinska Institutet, Stockholm, Sweden.

DOI: 10.1016/j.bjoms.2019.10.297

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MeSH Terms: Administration, Oral, Anticoagulants, Double-Blind Method, Humans, Postoperative Hemorrhage, Thromboembolism, Tooth Extraction, Tranexamic Acid, Vitamin K